Curriculum Vitae Stem cell

& Cancer
Indra Bachtiar, PhD Institute

Education

2002 – 2005 Postdoctoral Fellow at Laboratories of Biophysical Chemistry, NHLBI, National

Institute of Health (NIH), Bethesda, Maryland, USA
1998 – 2002 School of Pharmaceutical, Tohoku University, Sendai, Japan
1992 – 1994 Dept of Chemistry, ITB Bandung

Professional Career
2010 – Present Principal Investigator at Stem cell & Cancer Institute, PT. Kalbe Farma
2006 – 2010 Principal Investigator at MRIN Siloam, Lippo Karawachi
1992 – 2005 Lecture at Dept of Chemistry ITS Surabaya

Selected International Publications

2008 Kang C, Indra B, Grzegorz, et al: 2008., Biochemistry., 47, 2008
2009 Indra, B., Julian, M.S.., Beni A, et al.,”, Clinica Chimica Acta., 399., 97–101
2010 Indra, B., Gunawan., Velentine., Susan T., 2010, BMC Research Notes, 3:319
2011 Agus S, Akterono D B, Indra B et al., 2011, BMC Immunology,12:4
2012 Wahyu , Laura W, Teresa L. W, Indra B, et al, J Exp Integr Med 3(3) 225-230
2013 Wahyu , Laura W, Teresa L. W, Indra B, et al, Biomarkers and Genomic Medicine (6), 43-46.
2014 Andreas A.A, Wijaya L, Indra B et. al., Biomarkers and Genomic Medicine, Volume 7, Issue 3, Pages 87–
2015 Widowati, W, Krisa Y Kelvin; Indra B, Immunology, Endocrine & Metabolic Agents in Medicinal
Chemistry Volume 15, Number 2, pp. 128-137(10) Mahanani, Erlina Sih, Bachtiar, Indra, Ana, Ika Dewi;
Key Engineering Materials, Vol. 696, p205-211. 7p
Stemcell Application in Indonesia
Learning from International Regulation

Indra Bachtiar

Stemcell and Cancer Institute (SCI)

Members of The International Society For Stem Cell Research (ISSCR)
 History of Human Stem Cell Research (1998)
• In 1998, James Thomson (University of Wisconsin-Madison) isolated cells
from the inner cell mass of the early embryo, and developed the first human
embryonic stem cell lines.
Stem Cell: Raw Material of Human Body
MATURE Cell

STEMCELL
Undifferentiated Cell

Dfferentiation.
• If you do an online
search for ‘ stem cell
research ’ you will
retrieve over 5 million
hits world-wide from
sources such as:
• Research organisations
• Media
• Governments
• Companies
• Patient charities.
Rejuvenate
Potential of Stem Cells for Anti-aging
Controversy the Use of Stem Cells
Stem Cell Cream?
Why Stemcell Treatment
Become Uncontroled
Patient driven demand, often through
expectations around the promise of ‘stem cells’

Lack/low of Regulation and Punishment

Medical practitioners can directly access and

use human/Animal stemcells without the pre-
market scrutiny applied to medicines and
devices
The Most Important Issue Now Is
Where You Get The Stem Cells?
Is it real stemcell?
Legal?
Quality?
Is it real stemcell?
 NK cell, T Cell
etc

PB Mononuclear cell Haematopoetic

Stemcell (HSC)
Endothelial Progenitor cell
Blood peripheral (EPC)

PRP (Protein or growth factor Haematopoetic

Stemcell (HSC)
BM Mononuclear cell
Mesenchymal
BM Endothelial Progenitor cell
Bone Marrow (BM-EPC) Stemcell (MSC)

Stromal Vascular Fraction Mesenchymal

(SFV) Stemcell (MSC)

Adipose Tissue

Mesenchymal Stemcell
(UC-MSC)

Placenta/cord etc
Is It Legal?
Autologous, Allogeneic and Xenogeneic

Autologous/ Allogeneic/
Self-Donation Unrelated Donor

Xenogeneic/
Different species
Regulation for Autologous Stemcell
(1) Minimally manipulated, and
(2) Intended only for homologous use,
(3) Not combined with another article
(except for water, or sterilizing, preservation,or storage agents)
(4) Either:
a. Have no systemic or metabolic
effect, or
b. Before autologous use, allogeneic
use in first- or second-degree
blood relative, or reproductive use.
Regulation in Canada
 Stemcell Regulation in Indonesia

 Permenkes nomor 833/834 tahun 2009, tentang ‘Pedoman

Penyelenggaraan Pelayanan Medis Sel Punca’

 Permenkes nomor 48 tahun 2012, tentang

‘Penyelenggaraan Bank Sel Punca Darah Tali Pusat’

 Permenkes nomor 50 tahun 2012, tentang

‘Penyelenggaraan Laboratorium Pengolahan Sel Punca
Untuk Aplikasi Klinis’

 Permenkes nomor 32 tahun 2014 tentang ‘Penetapan

Rumah Sakit Pusat Pengembangan Pelayanan Medis
Penelitian dan Pendidikan Bank Jaringan dan Sel Punca.
Localized Autologous Therapy: Two Models
 Regulation in Indonesian

 When product is conducted in a closed system, cell

culture laboratories must have positive pressure relative
to the surrounding areas to avoid the inflow of
contaminated air.

 When cell processing is conducted in an open system,

it should be performed in cGMP qualification that
conforms to ISO-5 specifications (US Class 100) placed
in an environment classified as ISO-6 (US Class 10,00).
Regulation for Autologous Stemcell
Regulation for Allogeneic Stemcell
Allogeneic Stemcell is a Biological Drug
The Ideal Commercial Cellular Therapy
BPOM
Quality?
Product Quality
• Cell number/viability
• Number of passage
• Culture duration
• Cell characterization
In Process Control Stem Cell Processing in
cGMP Regenic Laboratory
• Sterility
• Mycoplasma
• Endotoxin test
In process control • Cell characterization
• Numbers and cell viability test
• Environmental monitoring

• Growth promotion test

Raw material &
• Growth inhibition test
consumables • Sterility

Routine
• Room qualification/cleaning every 2
Environmental weeks
Monitoring

• Equipment calibration (AHU, incubator,

Equipment Calibration biosafety cabinet, pipet and etc)

• Production, QC, delivery, cleaning,

Method Validation gowning and etc
Bone-Marrow Biopsy
 PATIENT REQUEST FORM

Lab screening result:

Anti-HIV (-), HbsAg (-), Anti-HCV (-)

CMV IgG (-)/(+), CMV IgM (-)/(+), TPHA (-)/(+)

Biopsy schedule
Thank you

ReGeniC Laboratory
Jl. Jend. Ahmad Yani No. 2
Pulomas, Jakarta Timur 13210
Telp. 021-47860173 ext. 212

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